Delivery device and method of delivery

ABSTRACT

A delivery device can include a number of different features including, one or more of, but not limited to, the following. Shuttle and trigger retraction of an outer sheath. Arcuate movement of a trigger. An interlock device to prevent actuation of the trigger. An interlock device that can adjust the position of the outer sheath and the inner shaft. A retraction override switch and lock.

INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

Any and all applications for which a foreign or domestic priority claimis identified in the Application Data Sheet as filed with the presentapplication are hereby incorporated by reference under 37 CFR 1.57.

BACKGROUND OF THE INVENTION

1. Field of the Invention

Disclosed herein are delivery devices and methods of deliver. Certainembodiments are described with reference to sequential delivery ofmultiple intraluminal devices from a delivery device. The deliverydevices and methods can be used in procedures to treat atheroscleroticocclusive disease, though they are not limited to these procedures.

2. Description of the Related Art

There are a number of medical conditions and procedures in which adevice such as a stent is placed in the body to create or maintain apassage. There are a wide variety of stents used for different purposes,from expandable coronary, vascular and biliary stents, to plastic stentsused to allow the flow of urine between kidney and bladder.

Stents are often placed in the vascular system after a medicalprocedure, such as balloon angioplasty. Balloon angioplasty is oftenused to treat atherosclerotic occlusive disease. Atheroscleroticocclusive disease is the primary cause of stroke, heart attack, limbloss, and death in the US and the industrialized world. Atheroscleroticplaque forms a hard layer along the wall of an artery and can becomprised of calcium, cholesterol, compacted thrombus and cellulardebris. As the atherosclerotic disease progresses, the blood supplyintended to pass through a specific blood vessel is diminished or evenprevented by the occlusive process. One of the most widely utilizedmethods of treating clinically significant atherosclerotic plaque isballoon angioplasty, which may be followed with stent placement.

SUMMARY OF THE INVENTION

Currently available stents and stent delivery systems have manylimitations and drawbacks. There exists a continuing need forimprovement in intraluminal devices and associated delivery devices.

According to certain embodiments, a delivery device can be provided forsequential delivery of a plurality of intraluminal devices (e.g. stents,tacks, staples, etc.) held in a compressed state on the delivery device.For purposes of this disclosure the word tack will be used to describeone of many intraluminal devices which can be deployed from a deliverydevice. The delivery device can comprise a plurality of deliveryplatforms, each delivery platform configured for holding a tack in acompressed position on the delivery device and having a unique shape,such as a non-constant outer diameter, an hourglass shape, a taperedproximal half, ridges, dimples, etc. This unique shape can be positionedbetween annular pusher bands that may also be radiopaque markers.

In some embodiments, the unique shape is provided by a sleeve offlexible material with the unique shape surrounding a harder innershaft. Further, the annular pusher bands can be made of wire or sectionsof material to increase flexibility while remaining radiopacity.

A tack deployment method can include alignment of radiopaque markers onthe outer sheath and the tack to be deployed prior to deployment.

A method of marker band alignment and intraluminal device or tackdelivery can be performed. The method can include: advancing a deliverydevice with a plurality of tacks in a compressed state to a treatmentarea; each tack comprising a plurality of struts and a radiopaque markerpositioned in a central region of the tack, each tack being a same sizewith the radiopaque marker positioned in a same location; the deliverydevice comprising an inner core having a plurality of deliveryplatforms, each delivery platform having one of the plurality of tacks,and an outer sheath covering the inner core and the delivery platforms;the outer sheath having a radiopaque marker band positioned proximallyfrom a distal end; withdrawing the outer sheath until the radiopaquemarker band on the outer sheath and radiopaque marker on a first tack tobe delivered are aligned; aligning these two radiopaque markers with atreatment area such as a tissue dissection or lesion to be treatedbefore release of the tack; then withdrawing the outer sheath to releasethe tack.

In some embodiments, a delivery device can comprise an inner shaft, adelivery platform and an outer sheath. The delivery platform can includea pair of annular bands around the inner shaft, both of the annularbands having a first outer diameter and a sleeve. The sleeve can besecured to the inner shaft and positioned between the annular bands. Thesleeve can have a lower durometer than the inner shaft and optimallyalso lower than the pair of annular bands. The sleeve can further have anon-constant outer diameter being less than the first outer diameter ofthe annular bands. The delivery platform can be configured to receive anintraluminal device for deployment from the delivery device into avessel and to receive the intraluminal device between the annular bandsand on the sleeve. The outer sheath can be positioned on and slidableover the inner shaft and the delivery platform, the outer sheath havinga pre-deployment position covering the delivery platform and at leastone delivery position where the outer sheath is withdrawn exposing atleast one of the annular bands and the sleeve of the delivery platform.

According to some embodiments, a plurality of additional deliveryplatforms can be included for sequential delivery of a plurality ofintraluminal devices. Each additional delivery platform can comprise anadditional sleeve and an additional annular band. Each of the annularbands can have a radius on a proximal end and/or comprise a radiopaquehelical coil. The radiopaque helical coil can be encased in a polymerhaving a higher durometer than a polymer that forms the sleeve.

The sleeve can include any number of different shapes and sizes, and caninclude ridges, dots, dimples, etc.

In some embodiments, a delivery device can comprise an inner shaft, theinner shaft having a nose cone on the distal tip; a delivery platform;and an outer sheath. The delivery platform can comprise a pair ofannular bands secured to the inner shaft, both of the annular bandshaving a first outer diameter; and a sleeve secured to the inner shaftand positioned between the annular bands. The sleeve can have a lowerdurometer than the inner shaft and optionally also the pair of annularbands. The sleeve may further have a first constant outer diametersection and a second constant outer diameter section having a largerouter diameter than the first, but less than the first outer diameter ofthe annular bands, and the second constant outer diameter section havinga shorter axial length than the first constant outer diameter section,the sleeve further having a smooth tapered transition between the firstand second constant outer diameter sections. The delivery platform canbe configured to receive an intraluminal device for deployment from thedelivery device into a vessel and configured to receive the intraluminaldevice between the annular bands and on the sleeve. The outer sheath canbe positioned on and slidable over the inner shaft and the deliveryplatform. The outer sheath can have a pre-deployment position coveringthe delivery platform and at least one delivery position where the outersheath is withdrawn exposing at least one of the annular bands and thesleeve of the delivery platform.

An intraluminal device deployment method can include one or more of thefollowing steps. Advancing a delivery device with a plurality ofintraluminal devices in a compressed state to a treatment area. Each ofthe plurality of intraluminal devices can comprise a plurality of strutsand a radiopaque marker positioned in a central region of theintraluminal device. Each of the plurality of intraluminal devices canbe a same size with the radiopaque marker positioned in a same location.The delivery device can comprise an inner shaft having a plurality ofdelivery platforms, each intraluminal device of the plurality ofintraluminal devices positioned at a respective delivery platform of theplurality of delivery platforms, and an outer sheath covering the innershaft and the plurality of delivery platforms, the outer sheath having aradiopaque marker band positioned proximally from a distal end of theouter sheath, Withdrawing the outer sheath until the radiopaque markerband on the outer sheath and radiopaque marker on a first intraluminaldevice to be delivered of the plurality of intraluminal devices arealigned. Aligning the aligned radiopaque marker band and the radiopaquemarker with the treatment area before release of the first intraluminaldevice. Withdrawing the outer sheath to release the first intraluminaldevice. Withdrawing the outer sheath until the radiopaque marker band onthe outer sheath and radiopaque marker on a second intraluminal deviceto be delivered of the plurality of intraluminal devices are aligned.

In some embodiments of the method, aligning the aligned radiopaquemarker band and the radiopaque marker with the treatment area cancomprise centering the aligned radiopaque marker band and the radiopaquemarker at a tissue dissection before release of the first intraluminaldevice. In some embodiments of the method, withdrawing the outer sheathuntil the radiopaque marker band on the outer sheath and radiopaquemarker on the first intraluminal device to be delivered of the pluralityof intraluminal devices are aligned can comprise withdrawing the outersheath until a distal-most end of the outer sheath and a distal-most endof the first intraluminal device are aligned. In some embodiments of themethod, withdrawing the outer sheath until the radiopaque marker band onthe outer sheath and radiopaque marker on the first intraluminal deviceto be delivered of the plurality of intraluminal devices are aligned cancomprise withdrawing the outer sheath until the radiopaque marker bandis positioned at a middle of the first intraluminal device. In someembodiments of the method, the first intraluminal device can have asingle column of radiopaque markers and withdrawing the outer sheathuntil the radiopaque marker band on the outer sheath and radiopaquemarker on the first intraluminal device to be delivered of the pluralityof intraluminal devices are aligned can comprise withdrawing the outersheath until the radiopaque marker band encircles the single column ofradiopaque markers.

In some embodiments, a delivery device can comprise an inner shaft, anouter sheath, an outer sheath rack, a handle housing, a shuttle, and atrigger. The inner shaft can have one or more delivery platforms fordeployment of one or more intraluminal devices. The outer sheath cansurround the inner shaft and be configured to cover the one or moredelivery platforms pre-deployment and to be withdrawn from at least oneof the one or more delivery platform as part of a deployment of the oneor more intraluminal devices. The outer sheath rack can comprise aplurality of teeth, the outer sheath rack coupled to the outer sheath.The inner shaft and the outer sheath rack are at least partiallypositioned within the handle housing. The handle housing can include atleast one pawl configured to engage with the plurality of teeth on theouter sheath rack to prevent re-sheathing of the outer sheath over theone or more delivery platforms after a deployment. The shuttle can havea pair of deflection arms configured for selective engagement with theplurality of teeth on the outer sheath rack. The trigger can bemechanically linked to the shuttle such that actuation of the triggercauses movement of the shuttle which withdraws the outer sheath fromcovering the one or more delivery platforms.

According to some embodiments, the plurality of teeth can comprise afirst plurality on the top of the rack and a second plurality on thebottom of the rack. The first plurality of teeth can comprise repeatingsets of teeth having a first tooth with a greater pitch than the otherteeth of the repeating set. The trigger can be configured such thatactuation of the trigger from a starting position to an end positionwithdraws the outer sheath from covering one of the one or more deliveryplatforms thereby releasing one of the one or more intraluminal devicesfrom the inner shaft. A counter and a shuttle pawl can also be included,wherein the shuttle pawl is configured to engage the counter to changean indication of a number of intraluminal devices available fordeployment.

In some embodiments, the handle housing can further comprise an arcuatechannel and the trigger is positioned within the arcuate channel to movein an arcuate path. A safety button can be provided to lock the triggerin place such that actuation of the safety button is required to allowactuation of the trigger.

In some embodiments, a control device can be provided for deploying aself-expanding medical device within the vessel of a living being. Thecontrol device can comprise a restraining sheath and a controlmechanism. The restraining sheath can have a proximal end and a distalend, the restraining sheath being adapted to extend over one or moreself-expanding medical devices to maintain the medical devices in acollapsed position and to be retractable to expose the one or morecollapsed medical devices for deployment. The control mechanism caninclude an actuation assembly coupled to the proximal end of therestraining sheath for retracting the restraining sheath, a sliderassembly being movable in an arcuate path of motion, the retraction ofthe restraining sheath being actuated by an actuating force applied by auser to a movable component of the control mechanism which moves in anarcuate path thereby changing the angle of force application and themechanical advantage of the force applied by a user depending on thelocation of the movable component along the arcuate path.

A delivery device according to some embodiments can include an innershaft, an outer sheath, a handle housing, an interlock and a rampinterface. The inner shaft can have one or more delivery platforms fordeployment of one or more intraluminal devices. The outer sheath cansurround the inner shaft and be configured to cover the one or moredelivery platforms pre-deployment and to be withdrawn from one of theone or more delivery platforms as part of a deployment of one of the oneor more intraluminal devices. The handle housing can have a triggermechanically linked to the outer sheath such that actuation of thetrigger withdraws the outer sheath from covering one of the one or moredelivery platforms. The interlock when in a locked position is engagedwith the trigger and the inner shaft to thereby prevent movement of theouter sheath. The ramp interface can be between the interlock and theinner shaft, wherein the ramp interface is configured to adjust theposition of the inner shaft relative to the outer sheath when theinterlock is removed from engagement with the inner shaft.

In some embodiments, the interlock can engage the trigger with a distalend of the interlock and engage the inner shaft with a proximal end. Theproximal end can engage the inner shaft and the handle housing. Thedistal end of the interlock can be hook shaped. The ramp interface cancomprise a first ramp on a protrusion of the interlock and a second rampon the inner shaft, wherein sliding disengagement of the first andsecond ramps forces the inner shaft to move.

According to some embodiments, a delivery device can include an innershaft, an outer sheath, an outer sheath rack, a handle housing, and aretraction override switch. The inner shaft can have one or moredelivery platforms for deployment of one or more intraluminal devices.The outer sheath can surround the inner shaft and be configured to coverthe one or more delivery platforms pre-deployment and to be withdrawnfrom one of the one or more delivery platform as part of a deployment ofone of the one or more intraluminal devices. The outer sheath rack cancomprise a plurality of teeth, the outer sheath rack coupled to theouter sheath, such as at the proximal end. The inner shaft and the outersheath rack are at least partially positioned within the handle housing.The handle housing can comprise at least one pawl configured to engagewith the plurality of teeth on the outer sheath rack to preventre-sheathing of the outer sheath over the one or more delivery platformsafter a deployment. The retraction override switch can be coupled to theouter sheath rack and the inner shaft, wherein actuation of theretraction override switch is configured to disengage the at least onepawl from the plurality of teeth on the outer sheath rack to allowre-sheathing of the outer sheath over the one or more delivery platformsafter a deployment.

In some embodiments, the delivery device can further comprise aretraction override lock feature, wherein the retraction override lockis configured to lock the retraction override switch in the actuatedposition with the at least one disengaged from the outer sheath rack.The retraction override lock can comprise a spring metal plate and theretraction override switch further comprises a cam engaged with thespring metal plate, actuation of the cam can move the cam to a lockedposition that prevents further movement. The outer sheath rack and outersheath can be coupled to the retraction override switch such thatactuation of the retraction override switch causes the outer sheath rackto move out of engagement with the at least one pawl. The retractionoverride switch can be configured such that actuation of the retractionoverride switch causes the retraction override switch to rotate withrespect to the handle housing. The outer sheath rack can be configuredsuch that actuation of the retraction override switch causes the outersheath rack and the outer sheath to rotate with respect to the handlehousing.

In some embodiments, a system is provided for deploying two or moreintraluminal devices within the vessel of a living being. The system cancomprise two or more intraluminal devices. Each intraluminal device maycomprise at least one radiopaque marker. An inner shaft of the systemcan have a proximal end and a distal end, the distal end having two ormore delivery platforms for deployment of the two or more intraluminaldevices, each intraluminal device in a collapsed state and located in aseparate delivery platform. A restraining sheath can be provided havinga proximal end and a distal end, the restraining sheath being adapted toextend over the one or more intraluminal devices to maintain theintraluminal devices in a collapsed position and to be retractable toexpose the one or more collapsed intraluminal devices for deployment.The restraining sheath may further comprise a sheath radiopaque markerin a distal portion of the sheath located at a set distance with respectto the most distal intraluminal device. A control mechanism can includean actuation assembly coupled to the proximal end of the restrainingsheath for retracting the restraining sheath with respect to the innershaft. The retraction of the restraining sheath can be actuated by anactuating force applied by a user to a movable trigger component of thecontrol mechanism. Actuation of the trigger from a starting position toan end position can completely withdraw the outer sheath from coveringone of the one or more delivery platforms thereby releasing one of theone or more intraluminal devices from the inner shaft into a locationwithin living being. This can also locate the sheath radiopaque markerat the distal end of the restraining sheath the set distance withrespect to the remaining most distal intraluminal device.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments are depicted in the accompanying drawings forillustrative purposes, and should in no way be interpreted as limitingthe scope of the inventions, in which like reference characters denotecorresponding features consistently throughout similar embodiments.

FIG. 1 is a side view of a delivery device that has been shortened tofacilitate illustration,

FIG. 2 shows a view of the distal end of the delivery device with anouter sheath withdrawn.

FIG. 3 shows an embodiment of intraluminal device or tack.

FIG. 3A shows a flattened section of the tack of FIG. 3.

FIG. 4 illustrates a detail view of the distal end of the deliverydevice with the outer sheath partially withdrawn.

FIG. 5 is a cross section of a delivery device showing an embodiment ofdelivery platform.

FIGS. 6A-E illustrate various embodiments of delivery platforms havingdifferent shapes.

FIGS. 7A-C illustrate certain steps of a deployment method.

FIG. 8 shows a handle at a proximal end of another embodiment ofdelivery device.

FIG. 9 is a partially disassembled view of the handle of FIG. 8.

FIG. 10 is a side view of the handle of FIG. 9 in a first position.

FIG. 10A is a representation of a portion of the distal end of thedelivery device when the handle is in the first position of Figure TO.

FIG. 10B is a detail view of a portion of the handle showing a shuttle.

FIG. 11 is a side view of the handle of FIG. 9 in a second position.

FIG. 11A is a representation of a portion of the distal end of thedelivery device when the handle is in the second position of FIG. 11.

FIG. 12 is a side view of the handle of FIG. 9 in a third position.

FIG. 12A is a representation of a portion of the distal end of thedelivery device when the handle is in the third position of FIG. 12.

FIG. 13 shows a detail view of a retraction override switch in a firstposition.

FIG. 13A is a cross-section of the retraction override switch of FIG.13,

FIG. 14 shows a detail view of a retraction override switch in a secondposition.

FIG. 14A is a cross-section of the retraction override switch of FIG.14.

FIG. 14B shows a side view of the handle of FIG. 9 with the retractionoverride switch in the second position.

FIG. 15 shows a side view of the handle of FIG. 9 wherein the innershaft has been re-sheathed by the outer sheath.

FIG. 16 shows a cross-section of another embodiment of proximal luerhub.

FIG. 16A is an exploded view of the proximal luer hub and other parts ofa delivery device.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

A delivery device 10 can be used as part of a procedure to treatatherosclerotic occlusive disease. The delivery device can be used todeliver one or more intraluminal devices 2, such as tacks, to a site ofplaque accumulation. The tacks can stabilize the site and/or hold piecesof plaque out of the way of blood flow. It will be understood thatthough the delivery devices and methods described herein are describedprimarily with reference to vascular procedures, they can also be usedin treatments for other parts of the body.

FIGS. 1 and 2 illustrate an embodiment of delivery device 10 that can beused for sequential delivery of multiple intraluminal devices 2. Thedelivery device 10 can be used in procedures to treat atheroscleroticocclusive disease, though it is not limited to these procedures.

The delivery device 10 of FIG. 1, which has been shortened to facilitateillustration, highlights the distal 4 and proximal ends 6. The proximalend 6 can be held by a physician or other medical professional during amedical procedure. It is used to control delivery of one or moreintraluminal devices or tacks 2, FIG. 2 shows the distal end 4 with six(6) intraluminal devices 2, each positioned at a dedicated deliveryplatform 8. Comparing FIGS. 1 and 2, it can be seen that an outer sheath12 has been withdrawn from the distal end in FIG. 2. This reveals thedelivery platforms 8 and the respective intraluminal devices 2. Theintraluminal devices 2 are preferably self-expandable and are shown intheir compressed position to represent how they would fit in thedelivery platforms. In typical use, the outer sheath 12 would becovering the intraluminal devices 2 when in this position. As will bediscussed in more detail below, the outer sheath 12 can be withdrawn ina systematic manner to deploy one intraluminal device 2 at a time at adesired treatment location.

Relatively small intraluminal devices 2, for example with only one(FIGS. 3 & 3A) or two columns of cells, can be delivered at precisetreatment locations and space appropriately to not overlap. FIG. 3Ashows a flattened section of the tack of FIG. 3. It can be seen that asingle column of cells 14 are formed by two concentric rings ofundulating struts 16 connected by bridge members 18. The bridge members18 have a pair of anchors 20 and a radiopaque marker 22. Multiple smallintraluminal devices 2 can be used to treat a single or multiplelesions. This can minimize the amount of foreign material in the body,while providing needed holding forces. Various embodiments ofintraluminal devices and delivery devices are described in more detailin Applicants' related patent application Ser. No. 13/179,458 filed Jul.8, 2011, published as US 2012/0035705 (IVAS.002P4) and patentapplication Ser. No. 13/749,643 filed Jan. 24, 2013, published as US2013/0144375 (IVAS.002P6), both of which are incorporated by referenceherein and made a part of this specification.

Each radiopaque marker can be press-fit or swaged into a circular eyeleton the respective bridge member of the intraluminal device. Swaging is aforging process in which the dimensions of an item are altered usingdies into which the item is forced. Swaging is usually a cold workingprocess; however, it is sometimes done as a hot working process. Swagingis normally the method of choice for precious metals since there is noloss of material in the process. The radiopaque markers discussed hereinwith respect to the intraluminal devices and delivery devices can be anynumber of different materials, including gold, platinum and tantalum.

It will be understood, that the delivery devices and methods can also beused for other intraluminal devices 2, including larger devices, and arenot limited to use with intraluminal devices 2 having only one or twocolumns of cells.

Returning now to FIG. 1; the proximal end 6 of the illustratedembodiment will now be described. The delivery device 10 can include anouter sheath 12, a proximal housing 24, and an inner shaft 26. The outersheath 12 can be constructed as a laminate of polymer extrusions andbraided wires embedded in the polymer extrusions. Flexibility andstiffness can be controlled through the number of braid wires, the braidpattern and pitch of the braid. In other embodiments, the outer sheathcan be formed of a hypotube, such as a metal or plastic hypotube.Flexibility and stiffness of the sheath can be controlled by manyfeatures such as the slope and frequency of a spiral cut along thelength of the hypotube. The outer sheath may also include a radiopaque(RO) marker 28 at or near the distal end. In some embodiments, theradiopaque marker 28 can be an annular band spaced from the distal-mostend.

As shown, the outer sheath 12 is a braided shaft and the proximalhousing 24 is a bifurcation luer that connects to the outer sheaththrough a strain relief 30. The strain relief 30 can take any form, suchas being made of polyolefin or other similar material.

The bifurcation luer 24 has a main arm to receive the inner shaft 26 anda side arm. The bifurcation luer can be disposed at the proximal end ofthe outer sheath. The side arm includes a flushing port that is used toflush out air and increase lubricity in the space between the sheath andthe inner shaft.

A tuohy borst adapter, hemostatic valve, or other sealing arrangement 32can be provided proximal of or integrated into the bifurcation luer 24to receive and seal the proximal end of the space between the innershaft 26 and the outer sheath 12. The tuohy borst adapter can alsoprovide a locking interface, such as a screw lock, to secure therelationship between the outer sheath and the inner shaft. This canallow the physician to properly place the distal end without prematurelydeploying a tack.

The inner shaft is shown with a proximal luer hub 34 and deploymentreference marks 36. The deployment reference marks 36 can correspondwith the delivery platforms 8, such that the spacing between eachdeployment reference mark can be the same as the spacing betweenfeatures of the delivery platforms. For example, the space betweendeployment reference marks can be the same as the distance between thecenters of the delivery platforms,

In some embodiments, a distal most deployment reference mark, or a markthat is different from the others, such as having a wider band ordifferent color, can indicate a primary or home position. For example adeployment reference mark with a wider band than the others can bealigned with the proximal end of the bifurcation luer 24 or hemostaticvalve 32. This can indicate to a physician that the outer sheath is in aposition completely covering the inner shaft 26 proximal of the nosecone 38. In some embodiments, this alignment can also translate toalignment of the RO marker 28 on the outer sheath to a RO marker on thedistal end of the inner shaft 26.

In some embodiments, one or more of the deployment reference marks 36can represent the number of tacks that are within the system. Thus, oncea tack is released, the deployment reference mark 36 will be covered upand the physician can know that the remaining deployment reference markscorrespond with the remaining number of tacks available for use. In suchan embodiment, the proximal end of the bifurcation luer 24 or hemostaticvalve 32 can be advanced to be centered approximately between tworeference marks to indicate deployment.

Looking now to FIG. 4, a detail view of the distal end 4 of the deliverydevice 10 is shown. Features of the illustrated embodiment include theinner shaft 26 with a distal soft tip 38. The tip 38 can be a taperednose cone. The nose cone 38 serve as a dilating structure toatraumatically displace tissue and help to guide the delivery devicethrough the vasculature. The tip itself 38 may be radiopaque, or aradiopaque element 27 can be incorporated into or near the tip. Aguidewire lumen 40 can be seen that extends through the inner shaft 26to the proximal luer hub 34 (FIG. 1). The guidewire lumen 40 isconfigured for receipt and advancement of a guidewire therein.

Parts of a delivery platform 8 are also shown. The delivery platforms 8are identical in the illustrated embodiment, though other embodimentscan have different sizes and constructions between different deliveryplatforms. A crimped or compressed tack 2 is shown in the deliveryplatform 8.

As can be seen in FIGS. 2 and 4, one or more delivery platforms 8 can bedisposed on the inner shaft 26 adjacent the distal end 4 of the deliverydevice 10. Each of the delivery platforms 8 can comprise a recess 42extending positioned between a pair of annular pusher bands 44. FIG. 5shows a cross section of a delivery device at one embodiment of deliveryplatform 8A. In the illustrated embodiment, the proximal annular pusherband 44A of a first platform 8A is also the distal annular pusher band44A of the platform 8B located immediately proximal (only partiallyshown). The annular pusher band 44 has a larger outer diameter ascompared to the delivery platform at the recess 42. In some embodiments,the recess can be defined as the smaller diameter region next to, orbetween, one or two annular pusher bands and/or an additional feature onthe inner shaft 26,

One or more of the annular pusher bands 44 can be radiopaque markerbands. For example, proximal and distal radiopaque marker hands 44 canbe provided to make the ends of the platform 8 visible using standardvisualization techniques. The annular marker bands 44 can take anysuitable form, for example including one more of tantalum, iridium, andplatinum materials. In some embodiments, the pusher bands 44 can be 4 mmlong with 6.75 min recesses between them. A tack of 6.5 mm can bepositioned between the pusher bands 44. In some embodiments, the pusherbands can be between 50-70% of the size of the recess and/or the tack.In some embodiments, the pusher bands are about 60%. In otherembodiments, the pusher bands can be much smaller, at between 10-20% ofthe size of the recess and/or the tack. This may be the case especiallywith longer tacks. In some embodiments, at least the proximal ends ofthe pusher bands 44 can have a radius to help reduce potential forcatching on deployed tacks during retraction of the delivery device.

Reducing the difference in length between the recess and the tack canincrease the precision of placement of the tack, especially with tackshaving only one or two columns of cells. In some embodiments, the recesscan be less than 1, 0.5, 0.4, 0.3, 0.25, or 0.2 mm longer than the tack.The tack can be any number of different sizes, such as 4, 5, 6, 6.5, 8,10, or 12 mm in length.

The outer sheath 12 can be made of polyether block amide (PEBA), athermoplastic elastomer (TPE) available under the trade name PEBAX. Insome embodiments, the outer sheath 12 can have a thinner inner linermade of a polytetrafluoroethylene (PTFE) such as TEFLON. Any radiopaquemarker band(s) 28, or other radiopaque material may be positionedbetween these two layers. In other embodiments, the radiopaque markerband(s) 28, or other radiopaque material can be embedded within one ormore layers of the outer sheath 12. The radiopaque marker band(s) 28 canrange from 0.5 mm to 5 mm wide and be located from 0.5 mm to 10 mmproximal from the distal-most tip 52. In some embodiments, theradiopaque marker band(s) 28 can be 1 mm wide and 3 mm proximal from thedistal-most tip 52.

In the cross section of FIG. 5 it can be seen that a sleeve 46 ispositioned around the inner shaft 26 between the two annular bands 44,in some embodiments, a delivery platform 8 can comprise a sleeve 46surrounding a shaft 26, where the sleeve 46 is made of a differentmaterial, or has different material properties, than the shaft 26. Insome embodiments, the sleeve provides a material having a tackiness, agrip, a tread pattern, and/or other features to help the tack stay inplace in the delivery platform. In some embodiments, the sleeve can bemade of PEBA. The inner shaft according to some embodiments is acomposite extrusion made of a PTFE/polyimide composite. The sleeve canbe softer than (a lower durometer than) the inner shaft and/or thepusher bands 44. This may be the case even if made of similar types ofmaterials. In some embodiments, the sleeve can be a material having atackiness, a grip, a tread pattern, and/or other features to help thetack stay in place (e.g., longitudinal position with respect to theinner shaft) while the outer sleeve 12 is withdrawn. This can increasethe amount of control during deployment and reduce the likelihood thatthe tack will shoot out distally from the delivery platform (known inthe industry as watermelon seeding). In some cases the outer sheath canbe partially removed thereby partially exposing an intraluminal devicewhereby the intraluminal device can partially expand while beingsecurely retained by the delivery prior to full release.

The sleeve 46 can be sized so that with the tack 2 in the deliveryplatform 8 there is minimal to no space between the tack and the outersheath. In some embodiments, the sleeve 46 can be co-molded with orextruded onto the inner shaft 26. In some embodiments, the deliverydevice 10 can be formed with a single sleeve 46 extending over a lengthof the inner shaft 26. For example, the sleeve can extend from the firstdelivery platform to the last delivery platform. The annular bands 44may surround distinct sections of sleeve 46, or they may be encased bythe sleeve 46. In some embodiments, each delivery platform 8 has aseparate sleeve 46 positioned in the recess 42. The annular bands 44 maybe encased by a different material, or may not be encased at all.

As will be understood from FIG. 5, the sleeve 46 can be cylindrical witha circular cross-section that is maintained across a portion of or theentire length of sleeve. In other embodiments, the sleeve has a uniqueshape and may include one or more of the following: tapering (FIGS.6A-E), an hourglass shape (FIG. 6A), ridges (FIG. 6B), dimples (FIG.6C), dots (FIG. 6D), two or more different diameters (FIG. 6E), etc.Features such as ridges, dots, and dimples can be positioned in numberof different patterns or groupings. In addition, the sleeve (FIGS.6B-D), or a section of the sleeve (FIG. 6E) can extend along less thanthe entire recess. In some embodiments, the length of the sleeve orlarger outer diameter section can correspond to the length of the tack.For example, the sleeve or larger diameter section can extend ¾, ⅔, ½,⅖, ⅓, ¼ of the recess and/or tack. Further, the length of the sleeve orlarger outer diameter section can be related to the size of struts inthe undulating ring 16, such as a proximal most undulating ring. Forexample, it can extend along the entire, ⅘, ¾, ⅔, or ½ of the length ofa strut or the length of the proximal most undulating ring. A shortsleeve, or a larger outer diameter section of a sleeve, preferablyextends from the proximal end of the recess distally (FIGS. 6D-E), butcan also be centered in the recess, positioned on at the distal end(FIG. 6C), or at other positions within the recess.

The sleeve of FIG. 6E is shown having two different constant outerdiameter sections with a short taper between them. The sleeve can beformed from two separate sections that are thermally bonded together.The tapered portion can also be created by thermal bonding so that thereis a smooth transition between the two constant outer diameter sections.As has been mentioned, the larger constant outer diameter sectionpreferably extends from the proximal end of the recess distally. Thislarger outer diameter section that may or may not have a constant outerdiameter can extend along less than the entire recess as has beendiscussed above.

In some embodiments, an inner shaft 26 can have a lower durometer sleeve46 between pushers 44. A tack 2 can be crimped onto the sleeve 46 and anouter sheath 12 can constrain the crimped tack in place. The clearancebetween the sleeve 46 and the outer sheath 12 can result in a slightinterference fit between the crimped tack 2 and the inner and outerelements. This slight interference allows the delivery system toconstrain the crimped tack during deployment until it is almostcompletely unsheathed allowing the distal portion of the tack to “flowerpetal” open and engage the vessel wall, reducing the potential forjumping.

According to some embodiments, the inner shaft 26 can be made of apolyimide-PEBA combination and the lower durometer PEBA sleeve 46 can bethermally bonded in between pushers 44. A tack 2 can be crimped onto thesleeve 46 and a PTFE lined outer sheath 12 can constrain the crimpedtack in place.

Returning to FIG. 5, a feature of certain embodiments of radiopaquemarker band 44 is shown. As has been mentioned, the sleeve 46 may encasethe annular bands 44, Alternatively, another material can encase themetallic bands to form the annular marker bands 44. The annular markerbands 44 can be made of wire 48 or multiple pieces of material or havingslits to increase flexibility while remaining radiopacity. In someembodiments the wire can form a helical coil that is wrapped around theinner shaft 26.

Moving now to FIGS. 7A-C, certain methods of deployment will now bedescribed. A delivery device 10 can be used as part of a procedure totreat atherosclerotic occlusive disease. The delivery device can be usedto deliver one or more intraluminal devices 2, such as tacks, to a siteof plaque accumulation. The tacks can stabilize the site and/or holdpieces of plaque out of the way of blood flow.

The tacks are preferably self-expandable. Thus, withdrawing the sheath12 to reveal a tack 2 allows the tack to deploy from the delivery device10 by self-expansion. The sheath can be withdrawn in small increments tosequentially deliver tacks at desired locations in a blood vessel. Insome embodiments, the small increments can correspond with thedeployment reference marks 36, The deployment reference marks 36 can bespaced apart at least the length of the tack, so that each tack can bedeployed at once, rather than the gradual release typical of a longerstent. This can allow for more precise placement of the tack.

Balloon angioplasty is an accepted method of opening blocked or narrowedblood vessels in every vascular bed in the body. Balloon angioplasty isperformed with a balloon angioplasty catheter. The balloon angioplastycatheter consists of a cigar shaped, cylindrical balloon attached to acatheter. The balloon angioplasty catheter is placed into the arteryfrom a remote access site that is created either percutaneously orthrough open exposure of the artery. The catheter is passed along theinside of the blood vessel over a wire that guides the way of thecatheter. The portion of the catheter with the balloon attached isplaced at the location of the atherosclerotic plaque that requirestreatment. The balloon is inflated to a size that is consistent with theoriginal diameter of the artery prior to developing occlusive disease.In some instances the balloon is coated with, or otherwise configured todeliver, a drug or biologic to the tissue. When the balloon is inflated,the plaque is broken. Cleavage planes form within the plaque, permittingthe plaque to expand in diameter with the expanding balloon. Frequently,a segment of the plaque is more resistant to dilatation than theremainder of the plaque. When this occurs, greater pressure pumped intothe balloon results in full dilatation of the balloon to its intendedsize. The balloon is deflated and removed and the artery segment isreexamined. The process of balloon angioplasty is one of uncontrolledplaque disruption. The lumen of the blood vessel at the site oftreatment is usually somewhat larger, but not always and not reliably.

Some of the cleavage planes created by fracture of the plaque withballoon angioplasty can form a dissection. More generally, a dissectionoccurs when a portion of the plaque or tissue is lifted away from theartery, is not fully adherent to the artery and may be mobile or loose.The plaque or tissue that has been disrupted by dissection protrudesinto the flow stream. If the plaque or tissue lifts completely in thedirection of blood flow, it may impede flow or cause acute occlusion ofthe blood vessel. There is evidence that dissection after balloonangioplasty must be treated to prevent occlusion and to resolve residualstenosis. There is also evidence that in some circumstances, it isbeneficial to place a metal retaining structure, such as a stent orother intraluminal device to hold open the artery after angioplastyand/or force the dissected material back against the wall of the bloodvessel to create an adequate lumen for blood flow.

A variety of delivery methodologies and devices can be used to deploy anintraluminal device, such as a tack 2, some of which are describedbelow. For example, a tack can be delivered into the blood vessel withan endovascular insertion. The delivery devices for the differentembodiments of plaque tacks can be different or the same and can havefeatures specifically designed to deliver the specific tack. The tackand installation procedure may be designed in a number of ways thatshare a common methodology of utilizing an expansion force of thedelivery mechanism (such as balloon expansion) and/or the expansionforce of an undulating ring to enable the tack to be moved into positionin the blood vessel, then released to an expanded state within the bloodvessel. A tack deployment method can include alignment of radiopaquemarkers on the outer sheath and the tack to be deployed prior todeployment.

Referring now FIG. 7A, a delivery device 10 with an outer sheath 12 isshown in a first pre-deployment position. Multiple tacks 2 can be heldby the outer sheath 12 in a compressed state within the delivery device10. In some embodiments, the tacks 2 are flash frozen in theircompressed state to facilitate loading onto the delivery device. Thetacks can extend over a given length of the delivery device as has beendescribed.

The delivery device can be advanced over a guidewire 50 in a patient'svasculature to a treatment site. The guidewire 50 can be the sameguidewire used in a prior step of a procedure, such as the guidewireused to position an angioplasty balloon. Once positioned at thetreatment location, the outer sheath 12 can be withdrawn or retracted tosecond pre-deployment position (FIG. 7B). The second pre-deploymentposition can be used to adjust the position of the outer sheath toaccount for any stretching, tortuosity, etc. that may require someadjustment before releasing a tack. In the second pre-deploymentposition, the distal end 52 of the outer sheath can be positioned at, orslightly distal of the distal end of a tack to be deployed.

According to some embodiments, the outer sheath 12 can have a radiopaqueannular marker band 28 and the tack can also have one or more radiopaquemarkers 22. The radiopaque markers 22 can be positioned in a columnaround the tack. The distance “L” from the distal end of the tack to theradiopaque marker 22 can be the same as the distance from the distal end52 of the outer sheath 12 to the radiopaque annular marker band 28. Insome embodiments, this distance is to the center of the markers 22 andmarker band 28. In some embodiments, the length “L” on the outer sheathis at least as long as the length “L” on the tack, if not slightlylonger. The outer sheath can be free from other radiopaque markers. Inaddition, the tack can also be free from other radiopaque markers orcolumns of radiopaque markers. Thus, the outer sheath can have only asingle marker band 28 at the distal end that is spaced from thedistal-most end 52 of the outer sheath 12 by at least a distance fromthe distal-most end of the tack 2 to a radiopaque marker 22 or column ofradiopaque markers. In the illustrated embodiment, the radiopaque marker22 or column of radiopaque markers are positioned in the middle of thedevice. The radiopaque markers are also positioned on bridge members 18that connect adjacent rings of undulating struts 16. In someembodiments, the radiopaque marker 22 or column of radiopaque markerscan be spaced from the distal-most end of the tack by at least one ringof undulating struts 16. In the illustrated embodiment, the radiopaquemarker 22 or column of radiopaque markers is not at the distal-most endof the tack 2, but is spaced therefrom.

Having corresponding radiopaque markers 22, 28 on the tack and the outersheath can allow the physician to align the markers 22, 28 prior todeployment of the tack. Further, the physician can align the alignedmarkers with the desired area to be treated. As will be understood, allof this alignment can be done using standard visualization techniques.As has been mentioned, the annular pusher bands 44 on the inner shaftcan also be radiopaque. In some embodiments, the pusher bands 44 can beidentical and can appear different under visualization than both themarker on the outer sheath and the marker on the tack. Thus, it can beclear to the physician where all of the markers are and which is which.For example, the pusher bands 44 can be axially longer than the marker28 on the outer sheath and the marker on the tack. Further, the markerson the delivery device can be bands, while the marker(s) on the tack canbe dots.

Looking to FIG. 7B, it can be seen that the marker 28 on the outersheath 12 and the markers 22 on the first tack 2 are aligned and thatthe distal end of the sheath is positioned at the distal end of thefirst tack. The delivery device can now be positioned with respect tothe lesion for treatment, such as by centering the radiopaque markers atdesired location. The sheath can then be withdrawn to place the tack inthe desired location,

In some embodiments, the delivery device can have a marker band on theouter sheath positioned proximally from the distal end-one at least halfthe length of the tack, the tack having a single column of markers atthe middle of the device. A method of deployment can include withdrawingthe outer sheath until the marker on the outer sheath and the tack to bedelivered are aligned, and then aligning these two markers with themiddle of the lesion to be treated (or other treatment area) beforerelease of the tack, the release being affected by further withdrawingthe outer sheath. It will be understood that markers on the pusher bands44 can also be used to help align the delivery device before deployment.

The method can be repeated to deliver multiple tacks (see FIG. 7C withtack shown in the compressed state for reference only). In between tackdeployment, the delivery device may be moved to a completely differentlesion or treatment area, or simply repositioned to ensure space betweenadjacent tacks once placed.

As discussed previously, in some embodiments, simultaneous placement ofthe entire tack can result upon release of the tack from the deliverydevice. Further, multiple tacks can placed as desired in a distal toproximal placement within the treatment segment of the vessel.

In some embodiments an expandable tack, such as that shown in FIGS. 3 &3A, can exert a relatively constant force to a wide range of vessellumen diameters, thereby allowing a single delivery catheter to deploymultiple tacks to varying sized vessels. Ideally the tack can bedesigned to treat vessels ranging in size from 2 to 8 mm, although othersized tacks could be delivered. It is desirable that the force appliedby the tack to the vessel varies 5N or less over a 3 mm expansion range.More ideally the force applied will vary 1.5N or less over a 3 mmexpansion range.

There are instances where drug coated balloons are being used as analternative to placing a stent in the vessel. The balloon can dilatenarrowing in the vessel and the drug helps to minimize post inflationinflammatory response which can lead to a re-narrowing of the artery.There is clinical evidence that the combination of a balloon and drugcan provide an alternative to the implantation of a typical stent whichhave been historically used to provide both short term and long termscaffolding. Drug coated balloons are desirable in that there is no longterm implant placed in the vessel. There are instances however when theexpansion of a drug coated balloon may cause damage to the vessel in theform of a tissue dissection in which case a flap or piece of tissueextends into the lumen of the vessel. The dissection can occur withinthe balloon treatment zone as well as outside of or adjacent to thetreatment zone. In these instances it is helpful to tack the dissectedtissue against the arterial wall. A tack having a low outward force canbeneficially be used to treat the dissection where a stent may not beappropriate, or desirable.

In some embodiments, the precise placement of the tack can be set uponpositioning of the catheter within the vessel based on the position of amarker. Once positioned, one or more tacks can then be deployed whilemaintaining the catheter in place and slowly removing the outer sheath.

In some embodiments, one or more tacks can be deployed at a dissectionof tissue. When an angioplasty procedure is performed there aretypically one of three outcomes: 1) an optimal outcome, no furtherstenting or over treatment needs to be performed, 2) residual stenosis,usually requiring the placement of a stent to prop open or scaffold thevessel so that it remains open and does not return to the prior occludedor partially occluded state, and 3) a tissue dissection. A tissuedissection can be where the vessel experiences trauma such as thedisruption of an arterial wall resulting in separation of the intimallayer. This may or may not be flow limiting. One or more tacks canbeneficially be deployed at such a tissue dissection. Small tacks allowfor the treatment of a subset of the portion of the blood vessel treatedby the balloon angioplasty procedure thereby providing a treatmenttherapy with does not require the implantation of long metal stents overthe entire angioplasty treatment area. Ideally, one or more tacks couldbe used to treat 60% or less of the length of vessel in the angioplastytreatment area. Small tacks having a single (illustrated) or doublecolumn of cells, have been shown to cause less injury and to haveshorter recovery times than commonly available stents in treating tissuedissections.

Upon placement of the tack, an intravascular construct is formed insitu. The in situ placement can be in any suitable vessel, such as inany peripheral artery. The construct need not be limited to just twotacks. In fact, a plurality of at least three intravascular tacks can beprovided in an intravascular construct formed in situ. In one embodimenteach tack has a length of no more than about 8 mm, e.g., about 6 mm inan uncompressed state. In one configuration, at least one of, e.g., eachof, the tacks are spaced apart from an adjacent tack by at least about 4mm, or between about 4 mm and 8 mm or between about 6 mm and 8 mm.Although certain embodiments have a length of 8 mm or less, otherembodiments can be longer, e.g., up to about 12 or 15 mm long. Also,neighboring tacks can be positioned as close as 2 mm apart, particularlyin vessels that are less prone to bending or other movements. In someembodiments, a delivery device can be preloaded with six tacks, eachabout 6.5 mm long, and can be used to treat lesions up to 15 cm inlength.

In the various delivery devices described herein, the spacing betweenimplanted tacks can be controlled to maintain a set or a minimumdistance between each tack. As can be seen, the delivery devices and/ortacks can include features that help maintain the desired distancebetween tacks. Maintaining proper inter-tack spacing can help ensurethat the tacks are distributed over a desired length without contactingeach other or bunching up in a certain region of the treated vessel.This can help to prevent kinking of the vessel in which they aredisposed.

While a three tack construct formed in situ may be suitable for certainindications, an intravascular construct having at least 5 intravasculartacks may be advantageous for treating loose plaque, vessel flaps,dissections or other maladies that are significantly more elongated(non-focal). For example, while most dissections are focal (e.g.,axially short), a series of dissections may be considered and treated asa more elongated malady.

In some cases, even shorter axial length tacks can be used to treat evenmore spaced apart locations. For example, a plurality of tacks, eachtack having a length of no more than about 7 mm, can be placed in avessel to treat a tackable malady. At least some of the tacks can bespaced apart from an adjacent tack by at least about 5 mm. In somecases, it may be preferred to provide gaps between adjacent tacks thatcan range from about 6 mm n to about 10 mm.

Optionally, once the tacks are in place, the angioplasty balloon can bereturned to the treatment site and inflated to expand the tacks to thedesired state of expansion.

Turning now to FIG. 8, an embodiment of a handle 60 for a deliverydevice is shown. The handle 60 can be used for controlled sequentialdelivery of tacks 2. The handle 60 can beneficially provide thephysician with a single-handed method of tack delivery, while alsoproviding increased precision in placement with consistent results,among other benefits,

The handle 60 can include a trigger 62 to control withdrawal of theouter sheath 12. For example, each actuation of the trigger 62 canwithdraw the outer sheath to expose a tack 2 and at least a portion of adelivery platform 8. The handle can also include a number of otherfeatures, such as safety features 64, 66, a counter 78, a proximal luerhub 34, and a retraction override 80. The functioning of the variousfeatures of the handle will be discussed in more detail below. It willbe understood that certain embodiments may include one or more of thedescribed features.

The handle 60 can include one or more safety features to preventpremature withdrawal of the outer sheath 12, such as by undesiredactuation of the trigger 62, For example, the handle 60 can include asafety button 64 that requires actuation at the same time as or beforeactuating the trigger 62. Further, the handle can include an interlock66. The interlock 66 can prevent actuation of the trigger, but can alsohelp maintain the relationship of the outer sheath 12 and inner shaft26.

Looking now at FIG. 9, the interlock 66 can be seen in more detail. Theinterlock 66 can remain in place until the physician is ready to deploythe tacks 2. It can hold the inner shaft 26 in place and preventsmovement of the trigger 62 which is mechanically linked to the outersheath 12. In the illustrated embodiment, the interlock 66 releasescomplete engagement with the handle 60 when removed.

The interlock 66 is shown engaging the trigger 62, the housing of thehandle 60 and the inner shaft 26. The interlock 66 can engage a slot 70on the trigger and a slot 72 on the handle body. In some embodiments,opposite ends 68, 74 of the interlock 66 can be used to separatelyengage the trigger slot 70 and the handle slot 72. Each end 68, 74 maysimply prevent movement of the inner shaft in one direction, or it canprevent movement in two directions.

The interlock can be shaped to allow connection and disconnection in aconsistent manner, such as in a first in-last out configuration. Asshown, the distal end 68 of the interlock 66 can extend into the triggerand requires rotation downward of the interlock 66 for removal. In someembodiments, distal end 68 of the interlock is hook shaped. The proximalend 74 can include a protrusion that advances into the slot 72. It willbe understood that this arrangement can be flipped and that theinterlock 66 can connect in other ways.

Further, in some embodiments, releasing the interlock 66 can alsoadvance the inner shaft 26 within the outer sheath 12. This can helpreposition and adjust the relationship between the inner shaft 26 withits delivery platforms 8 and the outer sheath 12. It can position theouter sheath in a ready position prepared for tack deployment. Theinterlock 66 and the inner shaft 26 can have a ramp interface 76. Theramp interface 76 can include a ramp on one or both of the interlock andthe inner shaft. For example, in some embodiments, the shuttle interlockcan include a ramp on the protrusion 74 and the inner shaft can includea rounded surface that interfaces with the ramp, but does not include anactual ramp.

Removing the interlock 66 with a ramp interface 76 can force the innershaft 26 to move distally in order for the ramp on the interlock 66 tocome out of the slot 72 in the handle housing. It can experience about 6mm of travel according to some embodiments, this can be a significantmovement as the tacks of some embodiments are 6.5 mm long as has beenpreviously discussed.

It will be understood that during advancement of the distal end of thedelivery device within the vasculature, the outer sheath and the innershaft will experience different forces due to friction and thetortuosity of the vessel. This initial adjustment of the inner shaft 26can help to rebalance the system, as well as moving the first deliveryplatform to the second pre-deployment position. Also, having the firstdelivery platform spaced proximally prior to deployment can help toensure that the first tack is not prematurely released.

The inner shaft 26 can be bonded to the proximal luer hub 34 which canbe fixed to the handle housing. This can prevent movement of the innershaft 26 relative to the outer sheath 12 at the proximal end, though thedistal end may experience some relative movement as has been mentioned.

Turning now to FIG. 10, it can be seen that the interlock 66 if part ofthe embodiment has been removed. The trigger 62 and safety button 64 cannow be actuated. The safety button 64 can be connected to a safetyrelease yolk 88. The yolk 88 can pivot at points “P”, such thatadvancing the safety button 64 pivots the yolk away from a protrusion ornotch 90 in the trigger 62. Engagement between the yolk 88 and theprotrusion 90 prevents the trigger from advancing. Once the yolk is outof the way, the trigger is free to move as can be seen in FIG. 11. Itwill be understood that the safety features can function in many otherways while providing similar benefits.

Reviewing FIGS. 10 and 11, it can also be seen that the trigger 62advances along a curved path. The handle housing can comprise an arcuatechannel and the trigger can be positioned within the arcuate channel tomove in an arcuate path. The trigger 62 can be spring loaded to bias itto the first extended position of FIG. 10, or starting position.Actuation of the trigger can compress the spring 86 and cause thetrigger to advance into the handle housing. This action of the triggercan be assisted by a lever 92. The lever 92 can have a pin or otherprotrusion 94 positioned within a slot 96 in the handle body. As thetrigger 62 advances upward, the pin 94 can slide forward in the slot 96.This can help so that the trigger does not bind up as it advances.

In some embodiments, control device can be provided for deploying aself-expanding medical device within the vessel of a living being. Thecontrol device can comprise a restraining sheath and a control mechanismor trigger. The restraining sheath can have a proximal end and a distalend, the restraining sheath being adapted to extend over one or moreself-expanding medical devices to maintain the medical devices in acollapsed position and to be retractable to expose the one or morecollapsed medical devices for deployment. The control mechanism caninclude an actuation assembly coupled to the proximal end of therestraining sheath for retracting the restraining sheath, a sliderassembly being movable in an arcuate path of motion, the retraction ofthe restraining sheath being actuated by an actuating force applied by auser to a movable component of the control mechanism which moves in anarcuate path thereby changing the angle of force application and themechanical advantage of the force applied by a user depending on thelocation of the movable component along the arcuate path.

Advancement of the trigger 62 can also cause movement of a shuttle 84.The shuttle 84 can be mechanically linked connected to the outer sheath12. Thus, advancement of the shuttle 84 can cause advancement of theouter sheath 12 to thereby withdraw the outer sheath 12 and deploy atack 2. Each full actuation of the trigger 62, moving from a startingposition to an end position, can cause the outer sheath 12 to withdrawsufficiently to deploy a tack and remain in the withdrawn position. Theshuttle 84 can also be spring loaded by a return spring 86. This cancause the shuttle 84 to return to its original or starting positionafter actuation of the trigger, while the outer sheath remains in itswithdrawn position. Thus, each advancement of the trigger 62 furtherwithdraws the outer sheath 12 from the distal end of the inner shaft 26.This can be seen by reviewing FIGS. 10A, 11A and 12A which represent aportion of the distal end of the delivery device when the handle is inthe respective first, second, and third positions of FIGS. 10, 11, and12,

When the shuttle returns to the initial position, the shuttle can engagea counter 78. The counter 78 can be a type of ratchet, such that eachengagement by the shuttle can ratchet the counter in the same direction,counting down the number of tacks that are available to deploy. In someembodiments, the shuttle comprises a counter pawl 98. The counter pawl98 can engage a different tooth on the counter 78 every time the shuttlereturns to the initial position. Reviewing FIGS. 10, 11, and 12 it canbe seen that the counter pawl 98 engages a tooth on the counter 78 andthen disengages (FIG. 11) as the shuttle is advances, and then engages anew tooth, causing the counter to advance or rotate (FIG. 12).

Turning now to FIG. 10B, a detail view of the shuttle 84 is shown. Theproximal end of the outer sheath can include an outer sheath rack 82.The rack can include a number of teeth 104, 110, 112 as will bedescribed in more detail below. The shuttle can engage and disengagewith the teeth 104 to advance the outer sheath rack 82 therebywithdrawing the outer sheath from the distal end of the inner shaft 26.A pawl 108 on the handle housing can engage one or more of teeth 110,112 to maintain the outer sheath in the withdrawn position.

The rack 82 can include one or more sets of teeth. As shown, the rackincludes a top set of teeth 110, 112 and a bottom set of teeth 104. Bothsets of teeth work to secure the outer sheath in place, though the topset of teeth are more specifically designed to prevent the rack fromreversing direction, and the bottom set of teeth are designed to governadvancement and withdrawal of the rack 82 by the shuttle. The shuttle 84can include one or more deflection members 100, 102. In the detail viewit can be seen that that shuttle 84 includes a pair of deflectionmembers 100, 102.

In an initial position, the deflection members 100, 102 can bepositioned on either side of a tooth 104. This can prevent the rack 82from moving with respect to the housing. The trigger 62 and shuttle 84can be mechanically linked so that actuation of the trigger 62 causesadvancement of the shuttle 84. As best seen in FIGS. 9 & 10B, thetrigger and shuttle 84 have a ramped interface 114. Ramps and/or angledsurfaces at the ramped interface 114 cause the shuttle to advanceproximally as the trigger moves upwards along the curved path. Aprotrusion 106 on the housing contacts the deflection member 100 as theshuttle advances. This allows the tooth 104 to move past the deflectionmember 100 as the deflection member 100 is force downwards as can beseen in FIG. 11. The pawl 108 engages the teeth 110, 112 on the top ofthe rack 82 to prevent the rack from moving distally after actuation ofthe trigger 62. Once the shuttle returns the initial position, thedeflection members 100, 102 engage a new tooth 104, as can be seen inFIG. 12. Looking at FIGS. 10-12A, it can be seen how the trigger andshuttle work through deployment of a first tack.

In some embodiments the rack 82 can include features that can allow forre-sheathing of the tack after a partial actuation of the trigger. Forexample, the pitch on a first tooth 110 can be increased as compared toother teeth 112. This can allow the user to start actuating the triggerand then re-sheath the tack. In the illustrated embodiment, the user hasthe ability to release the trigger at approximately ⅙ of the triggertravel (˜1 mm of tack exposed) and the outer sheath is able to re-sheaththe tack. Once the trigger is actuated beyond ⅙ of travel the pawl 108engages the next tooth 112 on the rack and prevents the outer sheathfrom re-sheathing the exposed tack. However, the pawl engagement on therack does give the user the opportunity to release the trigger duringpartial deployment while maintaining its position in the event thedelivery device needs to be repositioned. In other embodiments, thetrigger can be released and the tack re-sheathed after about ½, ⅓, ¼, or⅕ of the trigger travel. In some embodiments, the rack has a series ofteeth with a first tooth 110 having a greater pitch than adjacent teeth112. In some embodiments, the rack can have a space between a first setof teeth and a second set of teeth. For example, the tooth 110 can beremoved from the rack. In some embodiments, one or more teeth on therack can have a length that is ⅘, ¾, ⅔, ½, 40% ⅓, 30%, ¼ the length ofthe shortest strut on the distal-most end of the tack. Alternatively,two adjacent teeth can be spaced apart ⅘, ¾, ⅔, ½, 40% ⅓, 30%, ¼ thelength of the shortest strut on the distal-most end of the tack. Forexample, a short strut can be 2 mm long and a tooth can be 1 mm long.

Turning now to FIGS. 13-15, re-sheathing after deployment will now bedescribed. After a physician has determined that the delivery device isno longer needed, such as after delivery of one or more tack, it can bedesirable to re-sheath the distal end of the inner shaft 26 with theouter sheath 12. As re-sheathing could incorrectly lead a physician tobelieve that there are additional tacks that can be deployed, it mayalso be desirable to lock the outer sheath in place after re-sheathing.

The handle 60 can include a retraction override switch 80. Actuation ofthe retraction override switch 80 can disengage the internal lockingfeatures of the handle, such as the pawl 108 and one or more of thedeflection members 100, 102. In the illustrated embodiment, theretraction override switch 80 is a rotating lever. Rotation of the lever80 (FIG. 13 to FIG. 14) turns the teeth 104, 110, 112 on the rack 82 sothat they are no longer engaged by the deflection members 100, 102 orthe pawl 108 as shown in FIG. 14B. The outer sheath can then be advanceddistally to re-sheath the distal end of the inner shaft 26 with theouter sheath 12 as shown in FIG. 15,

The retraction override switch 80 can also include a locking feature.The locking feature can be used to ensure that the trigger cannot engagethe rack after re-sheathing. Looking now to FIGS. 13A and 14A anembodiment of the locking feature is shown. In FIG. 13A, the retractionoverride switch 80 is in a first disengaged position. A spring loadedmember 116, such as a spring steel plate, can engage one or moreprotrusions and/or slots on the retraction override switch 80. The oneor more protrusions and/or slots can be on a cam 118 that rotates aspart of the retraction override switch 80. The cam 118 can have a firstslot 120 that can engage the spring loaded member 116 during initial useof the handle, such as during actuation of the trigger. Once the desiredtacks have been deployed, the retraction override switch 80 can berotated, causing the cam to rotate. The slot 120 can become disengagedwith the spring loaded member 116. The cam can be rotated until a land124 contacts a surface (not shown) on the housing. The surface can be aprotrusion or other surface features that prevents further rotation ofthe cam. In that position, a second land 122 can engage with the springloaded member 116 and prevent the cam from being rotated in the reversedirection back to the prior initial position. In this way the rack cansecured on its side so that the trigger no longer works to advance theouter sheath proximally.

The outer sheath 12 can then manually be advanced distally to re-sheaththe distal end of the inner shall 26.

Turning now to FIGS. 16 and 16A, another feature of the delivery deviceis illustrated. Another embodiment of proximal luer hub 24′ is shown.The proximal luer hub 24′ can be similar to the proximal luer hub 24previously described. As will be understood, a sealing arrangement 32 isprovided that is integrated into the bifurcation luer hub 24′ to receiveand seal the proximal end of the space between the inner shaft 26 andthe outer sheath 12. The proximal luer hub 24′ can include a two pieceassembly with a seal housing 128 that attaches to the main housing.

There are a large number of patients with critical lower limb ischemiathat are unsuited for distal arterial surgical reconstruction and as aresult face major distal amputation. Methods such as balloon angioplastyand stenting provide an option to open the blocked or narrowed arteriesof these patients. These techniques generally require some level ofvessel patency so that a guide wire and catheter can be advanced to theblockage or narrowing for further treatment. In some patients thevessels are nearly or completely occluded and are therefore unsuitablefor many transvascular techniques. Distal venous arterialization is aprocedure in which the venous bed is used as an alternative conduit forperfusion of peripheral tissues. Via minimally invasive techniques, theblockage area of an artery is bypassed by using an adjacent venousconduit. Typically the most distal satisfactory artery is used forproximal bypass anastomosis. The venous valves, which function toprevent retrograde flow of blood in the venous system, are renderedincompetent or otherwise destroyed with probes, cutting balloons,Fogarty catheters, and valvulotomes to allow proper functioning as anarterial conduit. Alternatively the valves can be rendered incompetentwith a stent or tack which can be delivered with the multi-tack/stentdelivery system described herein.

Although this invention has been disclosed in the context of certainpreferred embodiments and examples, it will be understood by thoseskilled in the art that the present invention extends beyond thespecifically disclosed embodiments to other alternative embodimentsand/or uses of the invention and obvious modifications and equivalentsthereof. In addition, while a number of variations of the invention havebeen shown and described in detail, other modifications, which arewithin the scope of this invention, will be readily apparent to those ofskill in the art based upon this disclosure. It is also contemplatedthat various combinations or sub-combinations of the specific featuresand aspects of the embodiments may be made and still fall within thescope of the invention. Accordingly, it should be understood thatvarious features and aspects of the disclosed embodiments can becombined with or substituted for one another in order to form varyingmodes of the disclosed invention. Thus, it is intended that the scope ofthe present invention herein disclosed should not be limited by theparticular disclosed embodiments described above, but should bedetermined only by a fair reading of the claims that follow.

Similarly, this method of disclosure, is not to be interpreted asreflecting an intention that any claim require more features than areexpressly recited in that claim. Rather, as the following claimsreflect, inventive aspects lie in a combination of fewer than allfeatures of any single foregoing disclosed embodiment. Thus, the claimsfollowing the Detailed Description are hereby expressly incorporatedinto this Detailed Description, with each claim standing on its own as aseparate embodiment.

1.-14. (canceled)
 15. A delivery device for deploying a self-expandingmedical device within a vessel, the delivery device comprising: arestraining sheath having a proximal end and a distal end, therestraining sheath being adapted to extend over one or moreself-expanding medical devices to maintain the medical devices in acollapsed position and to be retractable to expose the one or morecollapsed medical devices for deployment; and a handle housing thatincludes an arcuate channel and a control mechanism including anactuation assembly coupled to the proximal end of the restraining sheathfor retracting the restraining sheath, a slider assembly comprising atrigger positioned within the arcuate channel, the trigger configured toslide within the arcuate channel in an arcuate path of motion from afirst extended position to a second position where the trigger isadvanced further into the housing as compared to the first extendedposition, the retraction of the restraining sheath being actuated by anactuating force applied by a user to a movable component of the controlmechanism which moves in an arcuate path thereby changing the angle offorce application and the mechanical advantage of the force applied by auser depending on the location of the movable component along thearcuate path.
 16. A system for deploying two or more intraluminaldevices within a vessel, the system comprising: two or more intraluminaldevices, each comprising at least one radiopaque marker; an inner shafthaving a proximal end and a distal end, the distal end having two ormore delivery platforms for deployment of the two or more intraluminaldevices, each intraluminal device in a collapsed state and located in aseparate delivery platform; a restraining sheath having a proximal endand a distal end, the restraining sheath being adapted to extend overthe one or more intraluminal devices to maintain the intraluminaldevices in a collapsed position and to be retractable to expose the oneor more collapsed intraluminal devices for deployment, the restrainingsheath further comprising a sheath radiopaque marker in a distal portionof the sheath located at a set distance with respect to the most distalintraluminal device; a control mechanism including an actuation assemblycoupled to the proximal end of the restraining sheath for retracting therestraining sheath with respect to the inner shaft, the retraction ofthe restraining sheath being actuated by an actuating force applied by auser to a movable trigger component of the control mechanism, whereinthe trigger is configured such that actuation of the trigger from astarting position to an end position completely withdraws the outersheath from covering one of the one or more delivery platforms therebyreleasing one of the one or more intraluminal devices from the innershaft into a location within the vessel, and further whereby the sheathradiopaque marker at the distal end of the restraining sheath is locatedat the set distance with respect to the remaining most distalintraluminal device and the trigger is configured such that a subsequentactuation of the trigger from the starting position to the end positioncompletely withdraws the outer sheath from covering the remaining mostdistal intraluminal device.
 17. The system of claim 16, wherein themovable trigger is configured to move in an arcuate path.
 18. The systemof claim 16, the control mechanism further comprising a rack with aplurality of teeth, the rack coupled to the restraining sheath; at leastone pawl configured to engage with the plurality of teeth on the rack;and a shuttle configured for selective engagement with the plurality ofteeth on the rack.
 19. The system of claim 16, wherein the sheathradiopaque marker is located a set distance from the distal end of therestraining sheath that is half an overall length of each of theintraluminal devices.
 20. The delivery device of claim 19, wherein thesheath radiopaque marker is 3 mm from the distal end of the restrainingsheath.
 21. The system of claim 16, wherein each of the two or moreintraluminal devices comprises a frame consisting of a single column ofcells extending circumferentially.
 22. The system of claim 21, whereinthe at least one radiopaque marker on each of the two or moreintraluminal devices comprises a plurality of radiopaque markerspositioned in the center of the intraluminal device spaced equidistantaround the circumference.
 23. The system of claim 16, wherein in a firstpre-deployment position the radiopaque marker in the distal portion ofthe sheath is aligned with the at least one radiopaque marker on themost distal intraluminal device.